The Wall Street Journal - Monday, 17 March 1997.
Bruce Ingersoll, Staff Reporter of The Wall Street Journal

The agency approved two protease inhibitors for treating pediatric AIDS patients: Norvir, an Abbott Laboratories drug now being taken by adults with AIDS, and Viracept, a drug developed by Agouron Pharmaceuticals Inc. Agouron, the latest entrant in the fiercely competitive AIDS-drug market, also was given the go-ahead to market Viracept for adult use.

To the frustration of parents and AIDS activists, protease inhibitors have been available only to the sickest of children aged two to 13. Pediatricians are reluctant to prescribe a drug that hasn't been thoroughly tested in clinical trials for possible adverse effects on children. For drug companies, there has been little financial incentive to develop pediatric data because only 7,200 children have been diagnosed with AIDS since 1981, compared with more than 550,000 adults.

But now those children will get the same benefits as adults from this new class of drugs, which inhibit protease, an enzyme critical to the reproduction of HIV, the AIDS virus. They are credited with the success of drug-combination "cocktails" that can reduce the virus to undetectable levels in AIDS patients.

"With each approval," said FDA Deputy Commissioner Michael Friedman, "we are providing more options in designing individualized treatment programs for adults and children."

Viracept is the fourth protease inhibitor to win the FDA's blessings. Roche Holding's Ltd. Invirase was approved for adults in December 1995, while Abbott's Norvir and the Merck & Co. drug Crixivan were cleared a year ago.

It was important for Abbott to win pediatric approval for its protease inhibitor at the same time as Agouron. The company has been criticized for being slow to compile pediatric data on Norvir, which was initially developed as a liquid, making it easy for infants and small children to ingest.

Abbott, based in North Chicago, Ill., contends the criticism is unwarranted. "Pediatric development of Norvir was remarkably fast by any accepted standard," said an Abbott spokesman. "It's unusual for a drug to be available for kids just one year after it's been approved for adults. That's quite an accomplishment."

Viracept, as an urgently needed drug, was put on the FDA's fast track and approved in just three months. The agency recommended using the drug in combination with other AIDS drugs. Viracept's most common adverse effect is diarrhea, which can usually be controlled with nonprescription drugs.

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